Mining and influencing factors analysis of sacituzumab govitecan adverse drug event based on FAERS database.

Abstract

Objective: Utilizing the FAERS database, this study aims to analyze the ADE signals of sacituzumab govitecan to provide references for clinical safety.

Methods: By searching the US FAERS database, we applied Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods to analyze ADE reports for sacituzumab govitecan from Q2 2020 to Q4 2023, covering 15 quarters.

Results: The total number of reports with sacituzumab govitecan as the first suspicion was 2854. A total of 139 signals involving 26 SOCs were obtained. The most reported were general disorders and administration site conditions (2,307 cases, 25.66%), followed by gastrointestinal disorders (1,125 cases, 12.52%), and investigations (810 cases, 9.01%). Frequent ADEs included sepsis and COVID-19 were not listed in the prescribing information. The signal strength analysis highlighted conditions like cholestasis and epilepsy not mentioned in the prescribing information. Furthermore, an analysis of influencing factors revealed differences in infections and infestations by gender and nationality (p < 0.05), and in gastrointestinal disorders and blood and lymphatic system disorders by gender, treatment duration, and nationality (p < 0.05).

Conclusions: Common ADEs generally correspond with the prescribing information. Clinicians should be vigilant regarding unlisted ADEs about sacituzumab govitecan, and close monitoring of laboratory indicators ensure patient medication safety.